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GEN-004 Low Dose

Phase 2

Pneumococcal Infections | Biologics | Infectious Disease |Genocea Biosciences, Inc.|Trials Updated: Apr 6, 2018

GEN-004 Low Dose development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment188

FDA Designations

No designations recorded

GEN-004 Low Dose clinical trials

GEN-004 Low Dose · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT02116998Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. PneumoniaePneumococcal Infections
COMPLETED98 Analytics
PHASE2COMPLETED
Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae
Pneumococcal Infections
NCT0211699898
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Study Endpoints

Primary Endpoints

Efficacy of GEN-004 with aluminum hydroxide in healthy adult subjects to reduce nasopharyngeal colonization following intranasal inoculation with S. pneumoniae serotype 6 as measured by proportion of colonized subjects
56 weeks
To evaluate the safety and tolerability of GEN-004 when administered with and without aluminum hydroxide to adult subjects.
12 months after third (last) dose

Secondary Endpoints

Safety and tolerability of GEN-004 with aluminum hydroxide
56 weeks
Duration of S. pneumoniae colonization through 14 days after inoculation
12 weeks
Immunogenicity of GEN-004 with aluminum hydroxide, as measured by TH17 (IL-17) and IgG responses to the vaccine antigens in sera and nasal fluid
56 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
GEN-004 with Aluminum HydroxideEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Low Dose (Cohort 1)EXPERIMENTAL -
Mid Dose (Cohort 2)EXPERIMENTAL -
High Dose (Cohort 3)EXPERIMENTAL -

Interventions

NameTypeDescription
GEN-004 with Aluminum Hydroxide AdjuvantBIOLOGICALGEN-004: 100 µg of each antigen, with adjuvant, 350 µg aluminum hydroxide, administered as a 0.5 mL intramuscular (IM) injection. GEN-004 is a recombinant S. pneumoniae protein subunit vaccine consisting of 3 recombinant T cell antigens: * GB104: ABC transporter, substrate-binding protein * GB144: Maltose/maltodextrin binding protein, ABC transporter * GB152: Hypothetical protein GEN-004 is filled in 2 mL vials containing 0.5 mL (350 µg/mL of each antigen). Aluminum hydroxide adjuvant is filled in 2 mL vials containing 1 mL at a concentration of 5 mg/mL.
PlaceboBIOLOGICALPlacebo: normal saline, 0.5 mL per dose, IM.
Streptococcus pneumoniae inoculationBIOLOGICALIntranasal inoculation of S. Pneumoniae (80,000 CFU/100μl per nostril) serotype 6B.
GEN-004 Low DoseBIOLOGICALThe GEN-004 Low Dose contains 10µg of each of the three antigens.
GEN-004 Low Dose + AdjuvantBIOLOGICALThe GEN-004 Low Dose contains 10µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
GEN-004 Mid DoseBIOLOGICALThe GEN-004 Mid Dose contains 30µg of each of the three antigens.
GEN-004 Mid Dose + AdjuvantBIOLOGICALThe GEN-004 Mid Dose contains 30µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
GEN-004 High DoseBIOLOGICALThe GEN-004 High Dose contains 100µg of each of the three antigens.
GEN-004 High Dose + AdjuvantBIOLOGICALThe GEN-004 High Dose contains 100µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males and non-pregnant females, ages 18 to 55 years inclusive. * Willing and able to provide written informed consent. * Fluent English speakers only (for safety reasons) * Willing to perform and comply with all study procedures including attending clinic visits as scheduled. ...

Countries:United KingdomUnited States
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